Diagnosis and treatment of giant cell arteritis.

Cranial and large vessel giant cell arteritis is a systemic vasculitis frequently found in Denmark. In recent years, considerable new knowledge has been gained in the field of diagnostics and treatment of giant cell arteritis. In this review, the clinical and radiological findings, treatment options and effect and side effects of treatment with tocilizumab are reviewed in a Danish context.

Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry.

OBJECTIVE: Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). METHODS: Observational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients. RESULTS: Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero. CONCLUSION: This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.

Effect of tofacitinib in a patient with inflammatory bowel disease-related arthritis.

Extraintestinal manifestations are common in patients with chronic inflammatory bowel disease (IBD). Peripheral arthritis occurs in ∼10% of patients with IBD. Treatment of both arthritis and the IBD disease is challenging, and involvement of both the rheumatologist and the gastroenterologist is essential. We present a case with concomitant polyarthritis and ulcerative colitis successfully treated with tofacitinib. A 32-year-old woman with ulcerative colitis currently treated with azathioprine and adalimumab was referred to our rheumatology clinic due to pain and swelling in her knees and finger joints. The patient was diagnosed with IBD-related arthritis. Intra-articular injection with steroid was initially effective, but the arthritis was persistent. Treatment attempts with salazopyrine and golimumab were discontinued due to drug-induced pancreatitis and urticaria, respectively. Subsequently treatment with tofacitinib 10 mg twice daily was effective within weeks, and apart from a mild folliculitis, there were no side effects. With this case report, we would like to draw attention to the fact that treatment with tofacitinib may constitute a good treatment option in refractory cases of IBD-related arthritis.

Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial.

OBJECTIVES: In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA). METHODS: Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication). RESULTS: Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched. CONCLUSION: This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.

[Successful treatment of alopecia totalis with tofacitinib in a Danish patient].

Alopecia totalis (AT) is characterised by extensive hair loss on the scalp, and common treatments are rarely effective. Janus kinase inhibitors represent a potentially new treatment modality in AT. In this case report, AT was successfully treated with tofacitinib in a 43-year-old male patient. After six months of treatment, the patient regained all his hair, and no relapse was seen after one year of treatment.